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Medical Device User Fee Act

FDA Plans Reduced Medical Device User Fees for 2012

The US Food and Drug Administration will reduce medical device user fee rates for its 2012 fiscal year, due to $9.5 million in excess appropriations from 2011. The new rates have been published as US legislators and industry lobbying groups are aggressively questioning FDA arguments for fee increases when the Medical Device User Fee and Modernization Act comes up for renewal next year.

US FDA Opens Small-Business Medical Device User Fee Discounts to More Foreign Manufacturers

The US Food and Drug Administration has opened small business qualification to foreign companies--including those that have not submitted US income tax returns--and also eliminated establishment registration fee discounts for small businesses as part of the agency’s updated Medical Device User Fees for 2013.